Status:
TERMINATED
A Randomized, Controlled, Comparative Study of a Levonorgestrel Intrauterine System for the Prevention of Endometrial Cancer in Patients Aged 40-50 With BMI Greater Than 35
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
35-50 years
Brief Summary
Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of...
Detailed Description
Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of...
Eligibility Criteria
Inclusion
- Inclusion:
- Woman between 40-50 years of age. Body mass index (BMI) ³ 35. Benign (no hyperplasia or cancer) endometrial biopsy prior to randomization Has an intact uterus
- Exclusion:
- Present infection with gonorrhea or chlamydia or within the last 5 years. Bacterial vaginosis that does not respond to one course of antibiotics. History of pelvic inflammatory disease in the last 5 years. Patients who are pregnant or who desire to become pregnant Does not desire fertility History of deep venous thrombosis or pulmonary embolus
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00161226
Start Date
February 1 2004
End Date
June 1 2006
Last Update
December 11 2009
Active Locations (1)
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1
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901